Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Indigo Medical, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
141 daysmedian FDA review time
446 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992262 | INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM | Indigo Medical, Inc. | 1999-10-04 | 90 | 0 |
| K990851 | INDIGO LASEROPTIC TREATMENT SYSTEM | Indigo Medical, Inc. | 1999-03-30 | 15 | 0 |
| K963969 | INDIGO PORTABLE LASER SYSTEM WITH TEMPERATURE FEEDBACK -MODE | Indigo Medical, Inc. | 1997-12-23 | 446 | 0 |
| K963081 | INDIGO MEDICAL MODEL IDL 830 & MODEL IDL 830E LASER SYSTEMS | Indigo Medical, Inc. | 1997-02-21 | 197 | 0 |
| K955758 | INDIGO MEDICAL MODEL IDL 830E | Indigo Medical, Inc. | 1996-02-16 | 59 | 0 |
| K954195 | INDIGO PORTABLE LASER SYSTEM, INDDIGO FIBEROPTICS | Indigo Medical, Inc. | 1996-01-25 | 141 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda